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RESULTS FOR FIRST QUARTER 2016 10 MAY 2016 Kjetil Hestdal, MD, President & CEO Erik Dahl, CFO PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY

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Page 1: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

RESULTS FOR FIRST QUARTER

2016

10 MAY 2016

Kjetil Hestdal, MD, President & CEO

Erik Dahl, CFO

PHOTOCURE ASA

BUILDING A

SPECIALTY PHARMA

COMPANY

Page 2: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

DISCLAIMER

The information included in this Presentation contains certain forward-looking statements that

address activities, events or developments that Photocure ASA (“the Company”) expects, projects,

believes or anticipates will or may occur in the future. These statements are based on various

assumptions made by the Company, which are beyond its control and are subject to certain

additional risks and uncertainties. The Company is subject to a large number of risk factors

including but not limited to economic and market conditions in the geographic areas and markets

where Photocure is or will be operating, IP risks, clinical development risks, regulatory risks,

fluctuations in currency exchange rates, and changes in governmental regulations. For a further

description of other relevant risk factors we refer to Photocure’s Annual Report for 2015. As a result

of these and other risk factors, actual events and our actual results may differ materially from those

indicated in or implied by such forward-looking statements. The reservation is also made that

inaccuracies or mistakes may occur in this information given above about current status of the

Company or its business. Any reliance on the information above is at the risk of the reader, and

Photocure disclaims any and all liability in this respect.

2

Page 3: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

DELIVERING ON KEY OBJECTIVES

3

KEY OBJECTIVES 1Q2016 KEY ACHIEVEMENTS

• Increase Hexvix/Cysview global in-market unit sales growth

rate

• Hexvix/Cysview global in-market volume

increased YoY 7%, with 25% volume

growth in own markets

• Hexvix/Cysview in-market value increased

YoY 19%

• BLC with Cysview recommended in new

American Urology Association bladder

cancer guidelines

• Finalize recruitment and reporting of clinical results of

Hexvix/Cysview phase 3 market expansion study in 2017

• Patient enrollment according to plan

• Secure Partnership for further development and

commercialization of Visonac and Cevira reflecting the

product potential

• Discussions ongoing with potential

partners

Commercial Franchise financial performance (EBITDA) improved

19% to 5.3 MNOK in 1Q2016

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Commercial Update

Page 5: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

HEXVIX/CYSVIEW

A SIGNIFICANT GLOBAL SPECIALTY BRAND

• Value of in-market sales of Hexvix/Cysview in

the first quarter increased YoY 19% to NOK

60 million

• Hexvix/Cysview global in-market volume

increased YoY 7% in the first quarter

• Overall franchise EBITDA for the first quarter

at NOK 5.3 million, improvement of 19% from

first quarter prior year

5

Global in-market unit sales (by Q)

Global in-market value NOK mill (LTM)

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HEXVIX/CYSVIEW

CONTINUED VALIDATION OF CLINICAL BENEFITS

• Use of Blue Light Cystoscopy with Cysview/Hexvix

recommended in the new AUA/SUO bladder

cancer guideline

– Recommended based on the large body of

evidence supporting both increased detection

and reduced recurrence of non-muscle invasive

bladder cancer

• New publication in Bladder Cancer shows

Cysview/Hexvix significantly prolongs time to

progression of bladder cancer

• Publication at European Association of Urology on

“real life experience” with Hexvix/Cysview confirms

the clinical benefits in routine clinical practice

6

Page 7: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

HEXVIX/CYSVIEW

SOLID PERFORMANCE IN NORDICS AND USA

• Photocure own sales revenue in the US and

Nordics increased YoY 38% in 1Q to NOK 17.7

million

• US revenue increased YoY 66% in the quarter

– Driven by YoY in-market volume growth of

37%, price increases and FX

– Permanent Blue Light Cystoscope placements

of 73 at the end of 1Q (2015 year end 65)

– Continued progress on passage of bill to

provide separate payment to hospitals

• Nordic revenue increased YoY 23% in the quarter

– In-market volume growth of 20%, partly due to

changed seasonality pattern

– Continued double digit in-market volume

growth in Sweden, first quarter 32% growth7

Own Hexvix/Cysview in-market unit sales

Nordic and US

Page 8: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

HEXVIX/CYSVIEW

PARTNER PROGRESS

• Partner revenue increased 14% in 1Q to NOK

15.8 million

– First quarter sales included the first shipment

to BioSyent Pharma in Canada

• End user YoY volume growth 2% in 1Q

• Strong visibility for Hexvix at European

Association of Urology congress

• New territories & partners

– BioSyent Pharma in Canada

• Expect commercial sales 2Q/3Q 2016

– Juno Pharmaceuticals in Australia and New

Zealand

• Expect MAA approval in Australia 2H 2016

• Russia: Marketing approval received

8

Hexvix Partner Unit Sales Per Quarter

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Pipeline Update

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HEXVIX/CYSVIEW

EXPANDING INTO THE SURVEILLANCE SEGMENT

10

• Surveillance following initial

diagnosis represents a

significant growth opportunity of

2-3 times current TURB

segment

• Patient enrollment in

Hexvix/Cysview Phase 3 market

expansion progressing

according to plan

• Study including 360 patients

examining improved detection

rate of Hexvix/Cysview blue light

cystoscopy vs white light

cystoscopy

• Study results expected in 2017

• Secured alignment with FDA on

study design necessary to obtain

label extension

Page 11: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

CEVIRA & VISONAC

PHASE 3 READY PRODUCTS WITH SIGNIFICANT

SALES POTENTIAL

• Cevira - Breakthrough single use and fully integrated drug-device

technology to satisfy high need for novel non-surgical therapies to treat

global epidemic of HPV/HSIL populations

• Visonac – Novel topical non-antibiotic/non-isotretinoin treatment to satisfy

high unmet medical need among patients with inflammatory, severe acne

(IGA 4)

• Cevira and Visonac both phase 3 ready with Special Protocol Agreement on

phase 3 program with FDA

• Cevira and Visonac both addressing large patient populations with

significant unmet medical needs

– Cevira with blockbuster sales potential based on premium pricing

opportunity in large patients populations

• Cevira and Visonac have granted patents with extensive patent life and

additional patent applications can provide additional extension

• Continued interest from potential partners for development and

commercialization

11

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Financials

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SEGMENTS

FIRST QUARTER 2016

• Commercial franchise:

– Continued revenue growth for

Hexvix/Cysview, First quarter growth

26% YoY (in constant currencies: 15%)

– Main growth drivers own sales in US

(+66%) and Nordic (+23%)

– Increased operating expenses driven by

sales & marketing in US and trials to

support surveillance market

– EBITDA increased 19%, margin at 15%

• Development portfolio:

– Activities related to regulatory work and

intellectual property

– Cysview post marketing commitment

phase 3 capitalized

13

MNOK Q1 '16 Q1 '15 Change

Commercial Franchise

Nordic revenues 10,1 8,3 23 %

US revenues 7,6 4,6 66 %

Partner revenues 15,8 13,9 14 %

Hexvix / Cysview 33,5 26,7 26 %

API revenues 0,0 1,7 -100 %

Signing fee & milestones 1,3 1,2 10 %

Total revenues 34,9 29,6 18 %

Gross profit 32,5 27,6 18 %

Operating expenses -27,2 -23,1 18 %

EBITDA 5,3 4,5 19 %

Development Portfolio

Operating expenses -9,1 -11,1 -18 %

EBITDA -9,1 -11,1 -18 %

Total

EBITDA -3,7 -6,6 -44 %

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PROFIT & LOSS

FIRST QUARTER 2016

• Total revenue increase YoY 18% in first

quarter

– Sales revenue negatively impacted by

reduced sales of API

• Operating expenses increase YoY 6%

in first quarter

– Sales & marketing increased 17%

– R&D reduced 28%

• EBITDA at NOK -3,7 million for first

quarter

– EBITDA improvement from 2015 of 44%

• EBIT impacted by amortization of

phase 3 Cysview

• Tax expenses are non cash, tax asset

14

MNOK Q1 '16 Q1 '15 Change

Total sales revenues 33,5 28,4 18 %

Signing fee and milestones 1,3 1,2 10 %

Total revenues 34,9 29,6 18 %

Gross profit 32,5 27,6 18 %

Operating expenses -36,2 -34,2 6 %

EBITDA -3,7 -6,6 -44 %

Depreciation & Amortization -1,1 -0,6 93 %

EBIT -4,9 -7,2 -32 %

Net financial items excl PCI 0,5 0,3 >100%

Profit/loss(-) before tax -4,4 -7,0

Tax expenses 3,6 -4,0

Net profit/loss(-) -0,7 -11,0 -94 %

Other comprehensive income 2,4 2,9 -17 %

Total comprehensive income 1,7 -8,1

Net result per share, diluted -0,03 -0,51

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CASH FLOW

FIRST QUARTER 2016

• First quarter cash flow from operations NOK -9.3 million, reduction of 22%

from 2015

– Change in working capital NOK -5.2 million, last year NOK -4,8 million

• First quarter cash flow from investments NOK -5.1 million.

– Includes investments of NOK 4.1 million in intangible assets mainly related to the

initiation of the phase 3 post-marketing commitment trial for Cysview

• Quarter end cash balance at NOK 120.6 million15

MNOK Q1 '16 Q1 '15 Change

Cash flow from:

- Operations -9,3 -11,9 -22 %

- Investments -5,1 -3,6 42 %

- Financing 1,0 0,0

Net change in cash -13,4 -15,5 -14 %

Ending cash balance 120,6 149,7 -19 %

Page 16: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

BALANCE SHEET

PER 31 MARCH 2016

16

• Non current assets include

investments in tangible and

intangible assets, NOK 8.6 million in

shares in PCI Biotech and deferred

tax asset of NOK 27.1 million

• Current assets include NOK 33.8

million in remaining settlement sale

of Metvix, due 31.12.2016

• No interest bearing debt

• Shareholder’s equity of NOK 213.5

million. Equity ratio of 86%

• Photocure held 809 own shares at

end of 1Q

MNOK 31.03 31.12

2016 2015

Non-current assets 54,6 43,6

Inventory & receivables 74,2 70,4

Cash & equivalents 120,6 134,0

Total assets 249,5 248,1

Shareholders equity 213,5 210,1

Long term liabilities 4,2 4,0

Current liabilities 31,8 34,0

Total equity & liabilities 249,5 248,1

Equity ratio 86 % 85 %

Page 17: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

Outlook

Page 18: PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY · PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY. ... including but not limited to economic and market conditions in the geographic

DELIVERING ON KEY OBJECTIVES

18

KEY OBJECTIVES 1Q2016 KEY ACHIEVEMENTS

• Increase Hexvix/Cysview global in-market unit sales growth

rate

• Hexvix/Cysview global in-market volume

increased YoY 7%, with 25% volume

growth in own markets

• Hexvix/Cysview in-market value increased

YoY 19%

• BLC with Cysview recommended in new

American Urology Association bladder

cancer guidelines in April

• Finalize recruitment and reporting of clinical results of

Hexvix/Cysview phase 3 market expansion study in 2017

• Patient enrollment according to plan

• Secure Partnership for further development and

commercialization of Visonac and Cevira reflecting the

product potential

• Discussions ongoing with potential

partners

Commercial Franchise financial performance (EBITDA) improved

19% to 5.3 MNOK in 1Q2016